Academic Journal
PATENCY-2 trial of vonapanitase to promote radiocephalic fistula use for hemodialysis and secondary patency
| العنوان: | PATENCY-2 trial of vonapanitase to promote radiocephalic fistula use for hemodialysis and secondary patency |
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| المؤلفون: | Peden, Eric K, Lucas, John F, Browne, Barry J, Settle, Stephen M, Scavo, Vincent A, Bleyer, Anthony J, Ozaki, Charles Keith, Teruya, Theodore H, Wilson, Samuel E, Mishler, Rick E, Ferris, Brian L, Hendon, Kendra S, Moist, Louise, Dixon, Bradley S, Wong, Marco D, Magill, Missy, Lindow, Francesca, Gustafson, Pamela, Burke, Steven K |
| المساهمون: | Proteon Therapeutics, Inc. |
| المصدر: | The Journal of Vascular Access ; volume 23, issue 2, page 265-274 ; ISSN 1129-7298 1724-6032 |
| بيانات النشر: | SAGE Publications |
| سنة النشر: | 2021 |
| الوصف: | Objective: Arteriovenous fistulas created for hemodialysis often fail to become usable and are frequently abandoned. This prospective trial evaluated the efficacy of vonapanitase, a recombinant human elastase, in increasing radiocephalic fistula use for hemodialysis and secondary patency. Methods: PATENCY-2 was a randomized, double-blind, placebo-controlled trial in patients on or approaching the need for hemodialysis undergoing radiocephalic arteriovenous fistula creation. Of 696 screened, 613 were randomized, and 603 were treated (vonapanitase n = 405, placebo n = 208). The study drug solution was applied topically to the artery and vein for 10 min immediately after fistula creation. The primary endpoints were fistula use for hemodialysis and secondary patency (fistula survival without abandonment). Other efficacy endpoints included unassisted fistula use for hemodialysis, primary unassisted patency, fistula maturation and unassisted maturation by ultrasound criteria, and fistula procedure rates. Results: The proportions of patients with fistula use for hemodialysis was similar between groups, 70% vonapanitase and 65% placebo, ( p = 0.33). The Kaplan–Meier estimates of 12-month secondary patency were 78% (95% confidence interval [CI], 73–82) for vonapanitase and 76% (95% CI, 70–82) for placebo ( p = 0.93). The proportions with unassisted fistula use for hemodialysis were 46% vonapanitase and 37% placebo ( p = 0.054). The Kaplan–Meier estimates of 12-month primary unassisted patency were 50% (95% CI, 44–55) for vonapanitase and 43% (95% CI, 35–50) for placebo ( p = 0.18). There were no differences in the proportion of patients with fistula maturation or in fistula procedure rates. Adverse events were similar between groups. Vonapanitase was not immunogenic. Conclusions: Vonapanitase treatment did not achieve clinical or statistical significance to meaningfully improve radiocephalic fistula surgical outcomes. Outcome in the placebo group were better than in historical controls. Vonapanitase was well-tolerated ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1177/1129729820985626 |
| الاتاحة: | http://dx.doi.org/10.1177/1129729820985626 http://journals.sagepub.com/doi/pdf/10.1177/1129729820985626 http://journals.sagepub.com/doi/full-xml/10.1177/1129729820985626 |
| Rights: | http://journals.sagepub.com/page/policies/text-and-data-mining-license |
| رقم الانضمام: | edsbas.6B9D8BB1 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1177/1129729820985626 |
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